Abstract 2219
Background
Racotumomab is an anti-idiotype vaccine, a mirror image of N-Glycolylneuraminic acid (NeuGcGM3), which mimics this ganglioside and triggers an immune response in various tumors. In this study we investigated the prognostic significance of tissue NeuGcGM3 expression level and prognostic as well as predictive value of circulating tumor cell count monitoring in patients on Racotumomab treatment.
Methods
Out of 48 patients characterized, 40 were non-small cell lung cancer (NSCLC), 12 stage III and 28 stage IV. 19 Adenocarcinoma and 21 Squamous Ca. 2 were small cell lung cancer (SCLC) and 6 with other carcinomas. Male/Female ratio was 3.36(37/11) and median age was 63 (31-84). All patients received Racotumomab as switch maintenance after chemotherapy. 7 PD-L1 (+) Pts also received check point inhibitors on progression. Expression of NeuGcGM3 was detected with 14F7 monoclonal antibody IHC staining and graded as 0,1+,2+ or 3+ according to intensity. Circulating tumor cell (CTC) count was monitored using Cell Sorter throughout the treatment course, before starting Racotumomab and every 3 months or on clinical progression.
Results
NeuGcGM3 IHC were performed 25 out of 48 patients whose paraffin blocks were available. 9 Patients had strong (3+), 12 had (2+) and 4 patients had (1+) NeuGcGM3 staining intensity. There was no statistically significant difference in the mean overall survival of the patients according to IHC staining level (1+) mean OS:55.3 months, (2+) mean OS:40.9 months, and (3+) OS:39.0 months. In 14 Patients, circulating tumor cell count was monitored from the blood and correlated well with clinical outcomes in 11 out of 14 patients (%78.5). Significant reduction of the CTC counts was compatible with clinical response whereas increased CTC counts were early messengers for clinical progression.
Conclusions
This study revealed that any grade of NeuGcGM3 positivity in the tumor tissue is adequate to select a patient for Racotumomab treatment regardless of the IHC intensity. We also concluded that CTC monitoring in patients receiving immunotherapy is a good predictive and prognostic tool.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Necdet Uskent.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
3630 - Results of phase 1 clinical trial of high doses of Seleno-L-methionine (SLM) in sequential combination with Axitinib in previously treated and relapsed clear cell renal carcinoma (ccRCC) patients
Presenter: Yousef Zakharia
Session: Poster Display session 3
Resources:
Abstract
2356 - Safety and Efficacy of CDX-014 , an Antibody-Drug Conjugate against T Cell immunoglobulin mucin-1 (TIM-1), in advanced Renal Cell Carcinoma
Presenter: Bradley McGregor
Session: Poster Display session 3
Resources:
Abstract
1028 - SPAZO2 (SOGUG): Outcomes and prognostic significance of IMDC intermediate prognosis subclassification in metastatic renal cell carcinoma (mRCC) in patients treated with 1st-line pazopanib (1stPz).
Presenter: Begona P. Valderrama
Session: Poster Display session 3
Resources:
Abstract
2293 - Effect of Antacid Intake on the Therapeutic Efficacy of Sunitinib (SUN) in Metastatic Renal Cell Carcinoma (mRCC) Patients (pts): a Sub-Analysis of the STAR-TOR Registry
Presenter: Katrin Schlack
Session: Poster Display session 3
Resources:
Abstract
1451 - Randomized phase 3 trial of avelumab + axitinib vs sunitinib as first-line treatment for advanced renal cell carcinoma: JAVELIN Renal 101 Japanese subgroup analysis
Presenter: Motohide Uemura
Session: Poster Display session 3
Resources:
Abstract
4399 - Overall and progression-free survival according to MSKCC scores in 1st line sunitinib treatment of metastatic renal cell carcinoma (mRCC)
Presenter: Jindrich Finek
Session: Poster Display session 3
Resources:
Abstract
1344 - Combination therapy with checkpoint inhibitors for first-line treatment of advanced renal cell carcinoma: A systematic review and meta-analysis of randomized controlled trials
Presenter: Kyaw Thein
Session: Poster Display session 3
Resources:
Abstract
3462 - A phase II trial of TKI induction followed by a randomized comparison between nivolumab or TKI continuation in renal cell carcinoma (NIVOSWITCH)
Presenter: Viktor Grünwald
Session: Poster Display session 3
Resources:
Abstract
5268 - Nivolumab (N) treatment beyond progression in a real-world cohort of patients (pts) with metastatic renal cell carcinoma (mRCC)
Presenter: Sophie Hans
Session: Poster Display session 3
Resources:
Abstract
4235 - First results of safety profile of nivolumab (NIVO) in combination with stereotactic body radiotherapy (SBRT) in II and III line of patients (pts) with metastatic renal cell carcinoma (mRCC) in NIVES Study
Presenter: Cristina Masini
Session: Poster Display session 3
Resources:
Abstract